Real Life Data for Otezla Evidence: Assessing Benefits of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis Followed by Dermatologists Under Real Life Settings in France
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 453
- 试验地点
- 93
- 主要终点
- Proportion of patients with Patient Benefit Index score (PBI-S) ≥1 at 6 months after initiation of apremilast.
研究概览
简要总结
REALIZE study will include a representative sample of 500 patients with moderate to severe plaque psoriasis for whom the treating dermatologist has decided to begin apremilast treatment in accordance with the local label reimbursement criteria. Patients may be enrolled into the study up to 4 weeks after starting the study treatment.
REALIZE is a longitudinal, multicenter, observational study under real life settings in patients with moderate to severe chronic plaque psoriasis after failure or contra-indication or intolerance to other systemic therapy including ciclosporin, methotrexate, or phototherapy UVA + psoralen (PUVA therapy).
详细描述
Eligible patients will be identified and invited to enroll from approximately 100 dermatologists in France practicing in public hospitals (or private clinics) or private practice. Patients will be followed over 12 months after initiation of apremilast or until discontinuation of apremilast whatever the earlier. Given the observational nature of the study, apremilast dosing and duration will be at the sole discretion of the treating dermatologist, in accordance with the local label and daily clinical practice. Patient care will follow routine clinical practice, involving regular follow-up visits, without any mandatory visit. In daily practice, patients are usually seen by their treating dermatologist every 6 months. In this study, patients will be followed up at most 12 months after apremilast initiation.
During this study, it is expected to collect data at inclusion (enrolment visit) and around 6 months and 12 months after apremilast initiation, on electronic case report forms (eCRF) by the dermatologist after performing a visit around 6 and 12 months to evaluate the treatment response following the apremilast initiation.
Due to the observational nature of the study, the study protocol does not require any specific tests or additional examinations. All assessments will be recorded in the electronic case report form (eCRF) according to the normal practice of the treating dermatologist. Self-questionnaires will be filled by the patient when visiting his/her dermatologist.
Total duration of the study is 2 years and 6 months, which includes an enrollment period of 1 year and 6 months and a follow up period of up to 1 year.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged at least 18 years
- •Patient with a diagnosis of stable moderate to severe chronic plaque psoriasis
- •For whom the treating dermatologist has made the decision to initiate apremilast treatment in accordance with the local label and reimbursement criteria i.e. a history of failure or contra-indication or intolerance to other systemic therapy including ciclosporin, methotrexate, or phototherapy UVA + psoralen (PUVA therapy)
- •Patient having started apremilast up to 4 weeks before the enrolment visit for treatment of moderate to severe chronic plaque psoriasis even if apremilast has been stopped before inclusion in the study
- •Patient literate and willing to fill in questionnaires
- •Non-opposition form signed by the investigator indicating that the patient received information about the study, and orally agreed.
排除标准
- •Patient who refuses to participate in the study or is unable to give his/her oral consent
- •Patient having participated in an interventional study in the last 30 days
研究组 & 干预措施
Patients treated with Apremilast
Patients with moderate to severe chronic plaque psoriasis after failure or contra-indication or intolerance to other systemic therapy including ciclosporin, methotrexate, or phototherapy UVA + psoralen (PUVA therapy).
干预措施: Apremilast (Drug)
结局指标
主要结局
Proportion of patients with Patient Benefit Index score (PBI-S) ≥1 at 6 months after initiation of apremilast.
时间窗: Up to 6 months
The PBI-S questionnaire for skin diseases is a validated instrument to assess treatment needs and benefits in patients with skin diseases. It comprises 23 items on patient-relevant therapy needs and benefits.
次要结局
- Proportion of patients with PBI-S=4 at 6 months after apremilast initiation(Up to 6 months)
- Adherence Rate(Up to 12 months)
- Percentage of patients substituting apremilast(Up to 24 months)
- Dermatology Life Quality Index (DLQI)(Up to 24 months)
- Proportion of patients with DLQI ≤ 5(Up to 24 months)
- Proportion of patients achieving DLQI 0/1(Up to 24 months)
- Change in DLQI score from M0 to M6 and M12(Up to 12 months)
- Proportion of patients with improvement in DLQI ≥ 5 points between M0 and M6, M12(Up to 12 months)
- Treatment Satisfaction Questionnaire for Medication (TSQM9)(Up to 24 months)
- Proportion of patients with sPGA 0 or 1(Up to 24 months)
- Change in sPGA from baseline to M6 and M12(Up to 12 months)
- Proportion of subjects with PBI-S (range 0-4) at 6 months after apremilast initiation(Up to 6 months)
- Percentage of BSA (%BSA) involved at M0, M6, M12(Up to 12 months)
- Change in % BSA from M0 to M6, M12(Up to 12 months)
- Psoriasis Area Severity Index (PASI) at M0, M6, M12(Up to 12 months)
- Change in PASI from M0 to M6, M12(Up to 12 months)
- Duration of previous chronic psoriasis treatment(Baseline)
- Proportion of patients achieving PASI50 at M6, M12(Up to 12 months)
- Proportion of patients achieving PASI75 at M6, M12.(Up to 12 months)
- Adverse Events (AEs)(Up to 24 months)
- Duration of disease(Baseline)
- Number of areas of plaque psoriasis(Baseline)
- Type of chronic psoriasis involved(Baseline)
- The number of lines of previous systemic treatments(Baseline)
- Type of systemic therapy previously administered(Baseline)
- Number of motivations of the prescription of apremilast(Up to 24 months)
- Percentage of motivations of the prescription of apremilast(Up to 24 months)